Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 15, 2023 | MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, la... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10F... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ9... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF V... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CD... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, R... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, R... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS9... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CD... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT,... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY -... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 13, 2023 | Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa... | Identification label on affected hookups could become illegible over time due to the label's ink ... | Class II | Steris Corporation |
| Nov 13, 2023 | Medtronic SynchroMed II, Model 8637-40, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... | Class II | Medtronic Neuromodulation |
| Nov 13, 2023 | Medtronic SynchroMed II, Model 8637-20, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... | Class II | Medtronic Neuromodulation |
| Nov 8, 2023 | Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Missi... | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter ... | Class II | Bard Peripheral Vascular Inc |
| Nov 3, 2023 | PVP SOLUTION SING STRL, REF DYNDA1858 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | Remington MEDICAL Drainage Bag, REF 600-D; | There is an error with the "Use by Date" and "Date of Manufacturer" on the box label. | Class II | Remington Medical, Inc. |
| Nov 3, 2023 | STERILE PVP SLN KIT, REF DYNDM1097 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE STERILE PREP STICK, REF DYNDA1134 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE PVP, REF DYNDA1649 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE BETADINE, REF DYNDA1998 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE POVIDONE, REF DYNDA2061 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 3, 2023 | STERILE PVP SOLUTION, REF DYNDA1907 | The product description on the labeling includes the word "Sterile" or STRL", however the content... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 1, 2023 | Atrium Oasis Drain Single W / AC, Part No. 3600-100 | A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expira... | Class II | Atrium Medical Corporation |
| Oct 27, 2023 | PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 | Due to incorrect product labeling | Class II | Limacorporate S.p.A |
| Oct 23, 2023 | stryker Sage PrimaFit External Urine Management System for the Female Anatomy | A small percentage of devices in three lots of product may contain a tape with a natural rubber l... | Class II | Sage Products Inc |
| Oct 19, 2023 | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 16, 2023 | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality ... | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws ... | Class II | Zimmer Biomet Spine Inc. |
| Oct 13, 2023 | AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product cod... | Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not bei... | Class II | Avanos Medical, Inc. |
| Oct 13, 2023 | Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revisi... | Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... | Class II | Corin Ltd |
| Oct 13, 2023 | Unity Total Knee System, Model Number 112.001.34. Primary and revision t... | Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity... | Class II | Corin Ltd |
| Oct 12, 2023 | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... | Class II | Medtronic Inc |
| Oct 12, 2023 | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... | Class II | Medtronic Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.